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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of LAE103 injection in healthy overweight/obese participants or healthy postmenopausal women. Study will also evaluate the safety, tolerability and preliminary pharmacodynamic effect of multiple dose injections in overweight/obese participants.
In addition, the study will also investigate the safety, tolerability of a single-dose co-administration of LAE102 and LAE103 in healthy overweight/obese participants.
This is a randomized, double-blind study comprising of a single-dose escalation study in healthy overweight/obese participants (Part A), a single dose study in healthy postmenopausal women (Part B), and a multiple-dose escalation study in healthy overweight/obese participants (Part C), designed to evaluate the safety, tolerability, Pharmacokinetics (PK )and pharmacodynamics (PD) profiles of LAE103 administered alone.
In addition, the study will also investigate the safety, tolerability, and PK/PD profiles of a single-dose co-administration of LAE102 and LAE103 in healthy overweight/obese participants (Part D).
About 104 participants will be enrolled in 13 cohorts with each cohort including 8 participants randomized 6:2 study drug:Placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm of single drug | Experimental | LAE103 injection, subcutaneous (SC) injection |
|
| comparator arm | Placebo Comparator | Saline |
|
| Treatment arm of combination | Experimental | LAE102 injection combined with LAE103 injection, single dose, subcutaneous (SC) injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAE103 injection | Drug | subcutaneous injection of LAE103 alone |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number & severity of participants with treatment-related adverse events | Findings on physical examination, ECG, vital signs, and reports of the laboratory results via investigator assessment | From Day1 to Day70 for single dose part. From Day 1 to Day98 for multiple dose part |
| Measure | Description | Time Frame |
|---|---|---|
| characterize the peak of serum concentration (Cmax) | evaluate the maximum observed serum concentration(Cmax) via LAE103 injection mono or LAE102 combined with LAE103 injection | From pre-dose to Day70 for single dose part. From pre-dose to Day98 for multiple dose part |
| characterize the time of reaching peak of serum concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Liu | Contact | 1-858-374-2717 | Juan.liu@laekna.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael Wong | Q-Pharm Pty Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Q-Pharm Pty Ltd. | Recruiting | Brisbane | Queensland | 4006 | Australia |
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| LAE102 injection in combined with LAE103 injection |
| Drug |
LAE102 injection in combined with LAE103 injection via subcutaneous |
|
| Saline | Drug | Saline via subcutaneous |
|
evaluate what time to reach the maximum serum concentration(Tmax) |
| From pre-dose to Day70 for single dose part. From pre-dose to Day98 for multiple dose part |
| characterize the area under the serum concentration versus time curve (AUC) | Evaluate the area under the serum concentration versus time curve (AUC) in LAE103 mono injection or LAE102 combined with LAE103 injection | From pre-dose to Day70 for single dose part. From pre-dose to Day98 for multiple dose part |
| Evaluate the expression levels of Activin A in blood samples | The validated methodology was employed to assay serum levels of Activin A in biological samples. | From pre-dose to Day70 for single dose part. From pre-dose to Day98 for multiple dose part. |
| Incidence of positive Anti-drug antibody(ADA) after administration | Test ADA status in biological sample via validated methodology | From pre-dose to Day70 for single dose part. From pre-dose to Day98 for multiple dose part. |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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